Project Manager, Operational Readiness

amgen; Holly Springs (NC); On-site; USD 110,000 - 148,000; Full time

Job summary

Amgen is seeking a Project Manager, Operational Readiness in Holly Springs, NC, to oversee startup, new product introduction, and inspection readiness programs. You will coordinate Manufacturing, Engineering, Quality, and Supply Chain activities to ensure safe, compliant, and timely transitions to routine operations.

Ideal candidates have extensive PM experience in regulated pharmaceutical settings, strong facilitation and stakeholder management skills, and familiarity with MS Project,

Qualifications

• Must have extensive project management experience in regulated pharma/biotech environments.
• Experience planning, coordinating, and executing Operational Readiness, startup, inspection readiness, or operational transition activities.
• Strong planning, scheduling, risk management, and stakeholder management skills.

Responsibilities

• Plan, coordinate, and execute Operational Readiness activities across multiple workstreams.
• Develop and maintain readiness plans, schedules, and risk logs.
• Coordinate cross-functional readiness efforts and ensure milestone delivery.

Skills

High school diploma / GED + 10 years

Associate’s degree + 8 years

Bachelor’s degree + 4 years

Master’s degree + 2 years

Doctorate degree

Education

High School Diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Job description

Career Category

Project Management

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

PROJECT MANAGER, OPERATIONAL READINESS

What you will do

Let’s do this. Let’s change the world. In this vital role you will plan, coordinate, and execute Operational Readiness activities, ensuring the organization is prepared to safely and compliantly deliver our startup, new product introduction, performance qualification, inspection readiness, and the transition to routine operations. You will directly support Manufacturing, Engineering, Quality, Supply Chain, Process Development, and Digital workstreams and work closely with Construction and Commissioning & Qualification teams to align readiness activities with project milestones.

• Facilitate scope development, planning, coordination, and execution of Operational Readiness and new product introduction activities across multiple workstreams.
• Develop and maintain readiness plans, schedules, action trackers, risk logs, and milestone tracking across functional workstreams.
• Define and track readiness requirements across personnel, training, procedures, systems, materials, and operational processes.
• Coordinate cross-functional readiness activities, monitor progress, identify gaps, and drive timely completion of deliverables.
• Facilitate readiness workshops, planning sessions, and working meetings to align stakeholders and address execution issues.
• Partner with Construction and Commissioning & Qualification teams to understand project milestones, turnover plans, and startup timelines, ensuring Operational Readiness activities remain aligned with facility delivery schedules.
• Track Operational Readiness dependencies, risks, constraints, and mitigation actions associated with project delivery and communicate readiness status to project teams and site leadership.
• Coordinate inspection readiness activities, including readiness assessments, action tracking, gap remediation, and support for regulatory inspections.
• Coordinate operational handover and startup stabilization activities to support a successful transition to routine operations.
• Capture lessons learned and implement improvements to Operational Readiness tools, processes, and execution practices.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The high-performing professional we seek is an effective facilitator with strong cross-functional project management and communication skills with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Project Management experience
• Associate’s degree and 8 years of Project Management experience
• Bachelor’s degree and 4 years of Project Management experience
• Master’s degree and 2 years of Project Management experience
• Doctorate degree

Preferred Qualifications:

• Experience planning, coordinating, and executing Operational Readiness, startup, inspection readiness, or operational transition activities within a regulated pharmaceutical or biotechnology environment.
• Working knowledge of facility turnover, commissioning, qualification, validation, startup, and operational handover processes.
• Experience coordinating cross-functional teams and delivering complex readiness activities without direct authority.
• Strong project planning, scheduling, organization, risk management, and issue‑resolution skills.
• Demonstrated ability to manage multiple priorities and deliver results in a fast‑paced project environment.
• Strong facilitation, communication, and stakeholder management skills.
• Proficiency with project planning and collaboration tools such as Microsoft Project, Smartsheet, Excel, and Microsoft Teams.
• PMP certification or an equivalent project management credential preferred.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $xxx,xxx.00 to $xxx,xxx.00. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

109,640.65USD -148,337.35USD